MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 1.5MM X 2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100152
Medical Device Problem Codes	Product Quality Problem (1506); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).[conclusion]: the healthcare professional reported that during the coil embolization of a difficult to access ruptured, dissecting aneurysm on the superior cerebellar artery (sca), the 1.5mm x 2cm deltaxsft 10 coil (dlx100152 / l11176) entered the target lesion before the physician could see its entrance; the physician noticed that the fluoro saver markers were offset and out of position on this coil.There was no friction between the coil and the sl-10® microcatheter (stryker) at any time prior to discovering that the marker bands were out of position; no friction was noticed until the very end during screening when the physician realized that part of the coil was already inserted in the aneurysm.It was reported that the distal-most marker band (the band closest to the patient) was positioned too far to the hub.Fluoroscopy was initiated when the coil was already approximately 1/3-1/2 protruded from the microcatheter.The coil was ultimately implanted in the aneurysm as expected, but the physician commented that he was not happy with the fact that the coil has been advanced into the aneurysm without him seeing it enter the aneurysm as this was a difficult case with a high risk of causing the patient to have a stroke.It was reported that there were five (5) other spectra coils (a 1.5mm x 3 cm deltaxsft 10, and 4 galaxy g3 minis coils: 2mm x 4 cm, 1.5mm x 2cm, 1mm x 3cm, 1mm x 3cm) used during the same procedure without the same event noticed.It was reported that the physician did not change the rotating hemostat valve (rhv) (merit mba), nor the microcatheter in between the coils.The reported event did not result in any patient injury or complication; there was no additional intervention performed.It was reported that the coil delivery wire was discarded and is not available to be returned for evaluation.Procedural images are also not available.Based on complaint information, the device remains implanted and is thus, not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l11176) 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.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 available and without the product available for analysis, the reported customer complaint could not be confirmed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 of a difficult to access ruptured, dissecting aneurysm on the superior cerebellar artery (sca), the 1.5mm x 2cm deltaxsft 10 coil (dlx100152 / l11176) entered the target lesion before the physician could see its entrance; the physician noticed that the fluoro saver markers were offset and out of position on this coil.There was no friction between the coil and the sl-10® microcatheter (stryker) at any time prior to discovering that the marker bands were out of position; no friction was noticed until the very end during screening when the physician realized that part of the coil was already inserted in the aneurysm.It was reported that the distal-most marker band (the band closest to the patient) was positioned too far to the hub.Fluoroscopy was initiated when the coil was already approximately 1/3-1/2 protruded from the microcatheter.The coil was ultimately implanted in the aneurysm as expected, but the physician commented that he was not happy with the fact that the coil has been advanced into the aneurysm without him seeing it enter the aneurysm as this was a difficult case with a high risk of causing the patient to have a stroke.It was reported that there were five (5) other spectra coils (a 1.5mm x 3 cm deltaxsft 10, and 4 galaxy g3 minis coils: 2mm x 4 cm, 1.5mm x 2cm, 1mm x 3cm, 1mm x 3cm) used during the same procedure without the same event noticed.It was reported that the physician did not change the rotating hemostat valve (rhv) (merit mba), nor the microcatheter in between the coils.The reported event did not result in any patient injury or complication; there was no additional intervention performed.It was reported that the coil delivery wire was discarded and is not available to be returned for evaluation.Procedural images are also not available.

• Brand Name: DELTAXSFT10 1.5MM X 2CM
• 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: 8625646
• Report Number: 3008114965-2019-01030
• Device Sequence Number: 16697349
• Product Code: KRD
• UDI-Device Identifier: 10886704077251
• UDI-Public: 10886704077251
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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: DLX100152
• Device Lot Number: L11176
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR