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

Catalog Number 4002C2060

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 11.5, 51.0 and 121.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.The introducer sheath was ovalized approximately 5.0 from the distal tip.Conclusions: evaluation of the returned device confirmed that the pusher assembly of the penumbra coil 400 (pc400) was kinked.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, damage such as kinks may occur.Further evaluation of the returned device revealed that the pc400 introducer sheath was ovalized.This type of damage typically occurs due to improper handling during use.If the rotating hemostasis valve (rhv) is overtightened during use, damage such as this may occur.The root cause of the reported resistance could not be determined.The non-penumbra balloon catheter, non-penumbra diagnostic catheter, and non-penumbra microcatheter mentioned in the complaint were not returned for evaluation.Penumbra coils are visually 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.

Event Description

The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous fistula (p-avf) using penumbra coils 400 (pc400s).It was noted that the patient anatomy was slightly tortuous.During the procedure, the physician advanced a non-penumbra diagnostic catheter through a non-penumbra balloon guiding catheter.Next, the physician advanced a non-penumbra microcatheter through the non-penumbra diagnostic catheter and non-penumbra balloon guiding catheter toward the treatment site.The physician then advanced 14 pc400s in the target vessel using the microcatheter.While attempting to advance a new pc400 through the same microcatheter, the physician experienced resistance midway through the microcatheter and subsequently, the pc400 became kinked; therefore, it was removed and a new pc400 was placed instead.The procedure was completed using eight pc400s, and two non-penumbra coils.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7084038
• MDR Text Key: 95069284
• Report Number: 3005168196-2017-02149
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010762
• UDI-Public: 00814548010762
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2017

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
• Device Operator: Physician
• Device Catalogue Number: 4002C2060
• Device Lot Number: F77227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2017
• Initial Date FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1