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

Catalog Number	4004C0820
Medical Device Problem Codes	Break (1069); Separation Failure (2547); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2017-01079.The device was discarded by the hospital.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using penumbra coils 400 (pc400's).It was noted that the patient anatomy was a bit tortuous.During the procedure, the physician placed a non-penumbra catheter in the celiac artery, then advanced a px slim delivery microcatheter (px slim) toward the treatment site.Next, the physician successfully deployed and detached two pc400's in the target vessel using a penumbra coil 400 detachment handle (dh1).While attempting to detach a new pc400 using the same dh1, the physician experienced difficulty and the pc400 failed to detach.It was reported that several attempts were made but the pc400 would not detach.Therefore, the physician attempted to pull the pull wire with a forceps and re-attempted to detach the pc400; however, the pc400 would still not detach.It was also reported that the pc400 pull wire became fractured in the middle.Therefore, the pc400 was removed and the procedure was completed using a non-penumbra coil without further issues.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6687220
• Report Number: 3005168196-2017-01078
• Device Sequence Number: 998779
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/06/2017

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: 10/29/2024
• Device Catalogue Number: 4004C0820
• Device Lot Number: F72564
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR