MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC OG TDL CMPLX FILL COIL 9X25; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0925
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (17710990) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the bronchial-artery embolization of an aneurysm at the bronchial artery, the microcatheter (carry leon, utm) was delivered to the distal end of the lesion and the 9mm x 25cm orbit galaxy complex fill coil (640cf0925 / 17710990) was inserted but there was resistance between the coil and the microcatheter as the coil got closer to the distal part of the of the microcatheter.The physician inserted and withdrew the coil several times, but the resistance became stronger.Due to the increased resistance, the physician decided to remove the coil and pulled on the coil.The coil delivery wire became separated at the distal blue part and became fragmented inside the microcatheter.The microcatheter was removed from the patient and it was flushed to push the coil and the separated delivery wire out.Another microcatheter and coil were used and there was also resistance experienced.The coil (unknown brand) detached in the middle of the microcatheter and the detached coil was implanted in the target lesion by flushing with a syringe.Additional coils were implanted using the same method of flushing with the syringe.The procedure was completed without any further issue or delay.There was no report of any patient injury or adverse event.The physician commented that there were some parts that caused strong resistance in the microcatheter, and it was possible that the microcatheter was kinked.The complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.It was reported that the product is available to be returned for evaluation and analysis.
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on (b)(6) 2019.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).The purpose of this mdr is to include the additional event information received on 4/2/2019.Sections with updated/added information: the initial reporter title, first and last names were added.The initial reporter phone: (b)(6) was added.[additional information]: the healthcare professional reported that during the bronchial-artery embolization (bae) of an aneurysm at the bronchial artery (ba), the microcatheter (carry leon, utm) was delivered to the distal end of the lesion and the 9mm x 25cm orbit galaxy complex fill coil (catalog #: 640cf0925 /lot #: 17710990) was inserted but there was resistance between the coil and the microcatheter as the coil got closer to the distal part of the of the microcatheter.The physician inserted and withdrew the coil several times, but the resistance became stronger.Due to the increased resistance, the physician decided to remove the coil and pulled on the coil.The coil delivery wire became separated at the distal blue part and became fragmented inside the microcatheter.The microcatheter was removed from the patient and it was flushed to push the coil and the separated delivery wire out.Another microcatheter and coil were used and there was also resistance experienced.The coil (unknown brand) detached in the middle of the microcatheter and the detached coil was implanted in the target lesion by flushing with a syringe.Additional coils were implanted using the same method of flushing with the syringe.The procedure was completed without any further issue or delay.There was no report of any patient injury or adverse event.The physician commented that there were some parts that caused strong resistance in the microcatheter, and it was possible that the microcatheter was kinked.The complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.It was reported that the product is available to be returned for evaluation and analysis.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device and to make corrections to the manufacture information.[conclusion]: the healthcare professional reported that during the bronchial-artery embolization (bae) of an aneurysm at the bronchial artery (ba), the microcatheter (carry leon, utm) was delivered to the distal end of the lesion and the 9mm x 25cm orbit galaxy complex fill coil (catalog #: 640cf0925 / lot #: 17710990) was inserted but there was resistance between the coil and the microcatheter as the coil got closer to the distal part of the of the microcatheter.The physician inserted and withdrew the coil several times, but the resistance became stronger.Due to the increased resistance, the physician decided to remove the coil and pulled on the coil.The coil delivery wire became separated at the distal blue part and became fragmented inside the microcatheter.The microcatheter was removed from the patient and it was flushed to push the coil and the separated delivery wire out.Another microcatheter and coil were used and there was also resistance experienced.The coil (unknown brand) detached in the middle of the microcatheter and the detached coil was implanted in the target lesion by flushing with a syringe.Additional coils were implanted using the same method of flushing with the syringe.The procedure was completed without any further issue or delay.There was no report of any patient injury or adverse event.The physician commented that there were some parts that caused strong resistance in the microcatheter, and it was possible that the microcatheter was kinked.The complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.The device was returned for evaluation.The investigational finding is documented below.Investigation summary: the non-sterile 9mm x 25cm orbit galaxy complex fill coil was received coiled and contained in a plastic bag.The returned device underwent visual inspection.The hub was observed to be without any damage.The hypotube was observed with several kink areas, the coil introducer was unzipped but there was no damage observed on the coil introducer.The coil gripper was observed broken into two.Microscopic inspection was performed.The support coil was kinked and has residues of dry blood inside.The embolic coil was outside the coil introducer but was observed to be in good condition.Due to the condition of the returned device, functional testing could not be performed.A review of manufacturing documentation associated with this lot (17710990) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue that the coil delivery wire became separated was confirmed through the visual inspection performed on the returned device.The observed broken coil gripper is likely due to excessive force that was inadvertently applied on the device; though the exact cause cannot be conclusively determined.The reported resistance issue between the coil and the microcatheter was not confirmed as the condition of the returned device precluded functional testing.However, the observed dry blood residues on the coil gripper suggests that adequate and continuous flush was not maintained during the procedure; this could have contributed to the reported resistance issue between the coil and the microcatheter and contributed to the coil delivery wire becoming separated when the physician was attempting to remove the coil by pulling on it.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: OG TDL CMPLX FILL COIL 9X25
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8409876
• Report Number: 1226348-2019-00836
• Device Sequence Number: 1922839
• Product Code: KRD
• UDI-Device Identifier: 10886704030409
• UDI-Public: 10886704030409
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 640CF0925
• Device Lot Number: 17710990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/13/2019; 04/02/2019; 05/15/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 03/13/2019; 04/02/2019; 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARRY LEON, DMS2020150, UTM MICROCATHETER