MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4006C0304
Medical Device Problem Codes	Detachment Of Device Component (1104); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 coils (pc400 coils).During the procedure, the physician deployed and detached initial pc400 coils into the target vessel using a px slim delivery microcatheter (px slim).While deploying the last pc400 coil, the physician retracted the coil in order to reposition it; however, it became stretched and then unintentionally detached within the px slim.The physician did not encounter any resistance while advancing or retracting the last pc400 coil through the px slim.The px slim containing the detached pc400 was then removed from the patient and the procedure was completed at this point with no additional coils needed.There was no alleged deficiency with the px slim.Additionally, there was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The embolization coil was detached from the pusher assembly and the stretch resistant (sr) wire was fractured.Conclusion: evaluation of the returned device revealed the sr wire was fractured.Although the physician reported no resistance was felt while retracting the pc400, sr wire fractures typically occur as a result of retracting the device against resistance, and may cause the embolization coil to become stretched and detached.The introducer sheath, embolization coil, and the px slim mentioned in the complaint were not returned for evaluation.Penumbra coils and catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5848419
• Report Number: 3005168196-2016-01118
• Device Sequence Number: 733530
• Product Code: HCG
• UDI-Device Identifier: 00814548011813
• UDI-Public: 00814548011813
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2016

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: Physician
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: 4006C0304
• Device Lot Number: F66693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2016
• Supplement Report FDA Received Date: 09/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR