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

Catalog Number CAT6

Device Problems Break (1069); Retraction Problem (1536); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 in the superficial femoral artery (sfa) and popliteal artery using an indigo system aspiration catheter 6 (cat6).It was noted that the patient¿s anatomy was not tortuous.During the procedure, the physician completed three passes using the same cat6 and a non-penumbra sheath.Upon completing the third pass, the physician decided to remove the cat6; however, resistance was encountered and the cat6 became stuck and would not come out of the vessel.The physician then pulled very hard to remove the cat6 and consequently, the cat6 broke within the patient and was sitting at the origin of the sfa.The patient then underwent a surgery to have the remaining portion of the cat6 successfully removed.The technologist reported that the non-penumbra sheath might have been pulled back over the iliac artery bifurcation which may have caused the cat6 to get stuck.The patient was in good condition after the surgical procedure but ultimately expired later the same day.The physicians who were present at the procedure did not attribute the patient¿s death to the penumbra device.Furthermore, the hospital staff attributes the patient¿s death to the multitude of issues he had going on and not to the penumbra device.

Manufacturer Narrative

Results: the indigo system aspiration catheter 6 (cat6) was kinked and ovalized in multiple locations throughout its length.The cat6 was fractured approximately 66.0 cm from the hub, with visible stretching of the polymer proximal to the fractured.Conclusions: evaluation of the returned device revealed the cat6 was ovalized and fractured, with visible stretching of the polymer proximal to the fracture.This type of damage typically occurs due to forceful retraction of the cat6 against resistance, as was reported in the complaint.The kink observed in the non-penumbra sheath likely contributed to the resistance experienced during the procedure, and the difficulty experienced when withdrawing the cat6.Further evaluation revealed the cat6 was kinked in multiple locations throughout its length.This damage may have occurred due to forceful manipulation of the cat6 while navigating patient anatomy, or forceful manipulation of the cat6 through the kinked non-penumbra sheath.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.

• 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: 6841681
• MDR Text Key: 84644910
• Report Number: 3005168196-2017-01479
• 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: 08/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/08/2020
• Device Catalogue Number: CAT6
• Device Lot Number: F74330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 51