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

Catalog Number CAT6

Device Problems Break (1069); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2016

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 6 (cat 6).During the procedure, the physician inadvertently crushed the cat6 tip while in the valve of the sheath.There was no report of an adverse effect to the patient.It is unknown how the procedure was completed.

Manufacturer Narrative

Results: the distal tip of the cat6 was ovalized.The cat6 was also ovalized approximately 8.0 cm from the distal tip.The cat6 was fractured approximately 107.0 cm from the hub.Conclusions: evaluation of the returned device revealed that the distal tip of the cat6 was ovalized.This type of damage likely occurred due to forceful handling during use.Further evaluation of the returned device revealed that the cat6 was fractured.This damage was likely incidental and likely occurred due to forceful handling while packaging the device for return.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.

• 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: 6198562
• MDR Text Key: 63555113
• Report Number: 3005168196-2016-01857
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

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
• Device Operator: Physician
• Device Expiration Date: 05/11/2019
• Device Catalogue Number: CAT6
• Device Lot Number: F69280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• 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