MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

Catalog Number CAT6

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the indigo system aspiration catheter 6 (cat6) was fractured and stretched approximately 46.0 cm from the hub.The stretched region of the cat6 began approximately 46.0 cm from the hub and ended approximately 72.0 cm from the hub.The cat6 was ovalized near its distal tip.The effective length of the cat6 was measured to be approximately 146.0 cm.Prior to decontamination, dried blood was observed throughout the cat6 lumen.Conclusions: evaluation of the returned device revealed the cat6 was stretched and fractured.This damage likely contributed to the cat6 becoming stuck on the wire, as was reported in the complaint.This damage likely occurred due to forceful retraction of the cat6 against resistance.It is possible for the cat6 to become pinned against other devices in the system or patient anatomy.If the cat6 becomes pinned or otherwise restrained, and is then forcefully retracted against said resistance, damage such as this may occur.Further evaluation revealed the cat6 was ovalized near its distal tip.This damage may have occurred due to pinching or forceful gripping of the cat6 during preparation for use or post-procedurally.The non-penumbra sheath mentioned in the complaint was not returned for evaluation.Penumbra 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.

Event Description

The patient was undergoing a thrombectomy procedure to treat a long segment superficial femoral artery (sfa) chronic total occlusion using an indigo system aspiration catheter 6 (cat6).During the procedure, while attempting to advance the cat6 over a non-penumbra guidewire through a non-penumbra sheath, the physician did not mention resistance; however, the cat6 became stuck on the wire and the physician decided to remove it along with the guidewire.Upon removal, the cat6 broke at the mid-shaft.The procedure was completed by performing a percutaneous transluminal angioplasty (pta).There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Type of Device: DXE
• 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: 7109212
• MDR Text Key: 95620923
• Report Number: 3005168196-2017-02189
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/17/2020
• Device Catalogue Number: CAT6
• Device Lot Number: F78735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• 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