MAUDE Adverse Event Report: SEE H.10 DELTAPL CERE COIL 10 SYS 3X6; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CPL10030630
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
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.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).Initial reporter information such as the name, phone and email address are not available/not reported.Conclusion: the healthcare professional reported that during the procedure with target vessel unknown, a distal kink was found on the 6f, 100 cm, mpd, xb envoy® guiding catheter (67025800b/30019773), and as a result of the kink, the 3 mm x 6 cm deltaplush 10 cerecyte coil (cpl10030630/c38446) was unable to advance through the guiding catheter.The devices were replaced to complete the procedure.There was no report of patient consequence, adverse event or any procedural delay associated with the reported issues.The 3 mm x 6 cm deltaplush 10 cerecyte coil was returned for evaluation which revealed that the coil was kinked and stretched.Based on the product analysis completed on 1/29/2019, this event has been deemed mdr reportable as a ¿malfunction.¿ investigation summary: the returned label on the device matched the complaint information.The embolic coil, returned as is in the green introducer sheath, was seen stretched beyond its 6 cm length.Kinks were observed on the device positioning unit (dpu) core wire at approximately 43, 63, 73, 96, 118, and 143 cm from the proximal end of the device.The device was then inspected under a microscope.The embolic coil distal ball tip was present and intact.The embolic coil was seen stretched inside the introducer.No damage or irregularities were seen to the coil distal of the stretched area.The proximal end of the embolic coil was seen kinked, stretched, and pressed into the distal end of the distal outer sheath.The coil could not be advanced from the sheath due to the condition in which it was returned.The skive of the sheath was opened in the product analysis lab to reveal the distal outer sheath had not been softened, indicating that the detachment process had not been initiated.The v-notch of the resheathing tool was seen undamaged.A review of manufacturing documentation associated with this lot (c38446) 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.Investigation conclusion: the complaint of detachable coil delivery system (dcs) impeded with no loss of cerebral target position is confirmed.The embolic coil was impeded in the introducer and could not be advanced due to the stretched and kinked condition in which it was returned.There is not enough information in the complaint to determine the cause of initial coil impedance.The device was likely the subject of excessive force, indicated by the multiple kinks on the dpu core wire, the stretching of the coil, and the proximal coil pressed into the distal outer sheath.The instruction for use (ifu) provides instructions for handling the device during delivery and provides instructions for when resistance is felt.Devices undergo 100% in-process inspection along the entire length of the embolic coil.In addition, all coils are advanced from the introducer sheath.It is unlikely that the device left the manufacturing facility with the observed damage.Coil kinked and stretched are known potential issues associated with the use of the device.The instruction for use provides proper handling instructions for the device to prevent issues such as kink and stretching from occurring.The coil kinked and stretched conditions were not originally reported with the complaint.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 observed kinked and stretched coil could not be conclusively determined; however, the likely cause is applied excessive force as indicated by the multiple kinks observed on the dpu core wire, the stretching of the coil, and the proximal coil pressed into the distal outer sheath.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.
Event or Problem Description
The healthcare professional reported that during the procedure with target vessel unknown, a distal kink was found on the 6f, 100 cm, mpd, xb envoy® guiding catheter (67025800b/30019773), and as a result of the kink, the 3 mm x 6 cm deltaplush 10 cerecyte coil (cpl10030630/c38446) was unable to advance through the guiding catheter.The devices were replaced to complete the procedure.There was no report of patient consequence, adverse event or any procedural delay associated with the reported issues.The 3 mm x 6 cm deltaplush 10 cerecyte coil was returned for evaluation which revealed that the coil was kinked and stretched.Based on the product analysis completed on 1/29/2019, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: DELTAPL CERE COIL 10 SYS 3X6
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8287664
• Report Number: 3008114965-2019-00898
• Device Sequence Number: 16562202
• Product Code: HCG
• UDI-Device Identifier: 00878528008286
• UDI-Public: 00878528008286
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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: 09/30/2020
• Device Catalogue Number: CPL10030630
• Device Lot Number: C38446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1