MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 2MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100206
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.Initial reporter phone and email are not available / reported.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).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 (l11206) 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 coil embolization procedure, the 2 mm x 6 cm deltaxsft 10 coil (dlx100206 / l11206) did not advance through the sl-10® microcatheter (stryker).The physician exchanged the microcatheter and encountered the same issue with the coil and the replacement microcatheter.A new 2 mm x 6 cm deltaxsft 10 coil from the same lot was used and the same issue with advancement was encountered; the coil would not advance through the microcatheter.A close examination was performed, and it was determined that the microcatheter did not have any issue, the coil was not able to advance through the introducer; the coil became stuck in the distal portion, the transparent green section.One of the coils was observed to have become prematurely detached inside the sleeve.It was reported that the rotating hemostat valve (rhv) did not have any issue.There was no report of any patient injury or complications associated with the event.The products are available to be returned for evaluation and analyses.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on (b)(6) 2019 and (b)(6) 2019.[additional information]:the healthcare professional reported that during the coil embolization procedure, the 2 mm x 6 cm deltaxsft 10 coil (dlx100206 / l11206) did not advance through the sl-10® microcatheter (stryker).The physician exchanged the microcatheter, another sl-10® microcatheter, and encountered the same issue with the coil and the replacement microcatheter.A new 2 mm x 6 cm deltaxsft 10 coil from the same lot (l11206) was used and the same issue with advancement was encountered; the coil would not advance through the microcatheter because it could not advance through the green introducer.A close examination was performed, and it was determined that the microcatheter did not have any issue, it was the coil that was not able to advance through the introducer; the coil became stuck in the distal portion, the transparent green introducer.One of the coils was observed to have become prematurely detached inside the introducer sleeve; the coil mechanically detached because it was stuck inside the green coil introducer, when the physician was trying to remove the coil, it became detached.The premature detachment issue occurred outside of the patient¿s body; it was reported that the issue occurred at the point where the rotating hemostat valve (rhv) is placed.It was reported that neither coils reached the microcatheter as the coils could not advance through the green introducer.When the coil was removed, there was no appearance of damage detected.Adequate and continuous flush was maintained through the microcatheter; it was reported that other coils were used with the microcatheter without any issue.It was reported that the rhv did not have any issue.There was no report of any patient injury or complications associated with the event.The reported event resulted in a 20-minute procedural delay that the physician deemed significant, because according to the physician, the 20-minute delay was less important than the fact that the microcatheter had to be removed to test if another microcatheter was the solution.The procedure was completed with the same microcatheter was used with competitor coils to complete the procedure.The physician insisted that the microcatheter was not involved.The product is available to be returned for evaluation.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 is to include the additional event information received on 10/21/2019.[additional information]: it was originally reported that the product is available to be returned for evaluation and analysis.However, additional information was received that the product is not available to be sent for return.[conclusion]: the healthcare professional reported that during the coil embolization procedure, the 2 mm x 6 cm deltaxsft 10 coil (dlx100206 / l11206) did not advance through the sl-10® microcatheter (stryker).The physician exchanged the microcatheter, another sl-10® microcatheter, and encountered the same issue with the coil and the replacement microcatheter.A new 2 mm x 6 cm deltaxsft 10 coil from the same lot: (l11206) was used and the same issue with advancement was encountered; the coil would not advance through the microcatheter because it could not advance through the green introducer.A close examination was performed, and it was determined that the microcatheter did not have any issue, it was the coil that was not able to advance through the introducer; the coil became stuck in the distal portion, the transparent green introducer.One of the coils was observed to have become prematurely detached inside the introducer sleeve; the coil mechanically detached because it was stuck inside the green coil introducer, when the physician was trying to remove the coil, it became detached.The premature detachment issue occurred outside of the patient¿s body; it was reported that the issue occurred at the point where the rotating hemostat valve (rhv) is placed.It was reported that neither coils reached the microcatheter as the coils could not advance through the green introducer.When the coil was removed, there was no appearance of damage detected.Adequate and continuous flush was maintained through the microcatheter; it was reported that other coils were used with the microcatheter without any issue.It was reported that the rhv did not have any issue.There was no report of any patient injury or complications associated with the event.The reported event resulted in a 20-minute procedural delay that the physician deemed significant, because according to the physician, the 20-minute delay was less important than the fact that the microcatheter had to be removed to test if another microcatheter was the solution.The procedure was completed with the same microcatheter was used with competitor coils to complete the procedure.The physician insisted that the microcatheter was not involved.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot: (l11206) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information provided in the complaint and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.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.Updated sections: g.4 (pma/510k), h.2 (if follow-up, what type), h.3 (device evaluated by mfr), h.6, and h.10.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: DELTAXSFT10 2MM X 6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8569828
• Report Number: 3008114965-2019-00995
• Device Sequence Number: 16577211
• Product Code: KRD
• UDI-Device Identifier: 10886704077336
• UDI-Public: 10886704077336
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2019

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: 12/31/2020
• Device Catalogue Number: DLX100206
• Device Lot Number: L11206
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 10/21/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/29/2019; 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1