MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G30958

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other non-healthcare professional: office manager. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during a percutaneous transluminal angioplasty of the left superficial femoral artery (sfa), an advance 18 lp low profile balloon catheter ruptured and separated. The patient¿s anatomy was extremely calcified; however, was not tortuous or angulated. The entire left sfa was diseased and eighty to ninety-five percent occluded, with a short (approximately 60mm) area of chronic total occlusion. The balloon was inflated three times to nominal pressure with an unknown inflation device and a 50/50 ratio of contrast to saline for approximately 30 to 40 seconds. The balloon did not go over burst pressure. The balloon was not removed and reinserted between inflations. After the balloon ruptured, the user attempted to pull the balloon off an unknown wire guide and into a cook sheath, using a counter-clockwise rotation; however, two-thirds of the balloon would not enter the sheath. The user continued to pull on the device and approximately ten to fifteen millimeters of the balloon separated and remained on the wire guide. A cook clover snare was then used to retrieve the separated portion of the balloon from the patient, via the left groin. The balloon was not inflated within a stent. Negative pressie was not maintained continuously during removal of the complaint device, as blood was noted in the inflation device.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 10828186
• Report Number: 1820334-2020-02077
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002309583
• UDI-Public: (01)10827002309583(17)230902(10)13404239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/02/2023
• Device Model Number: G30958
• Device Catalogue Number: PTA4-18-150-5-20
• Device Lot Number: 13404239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 80 YR
• Patient Outcome(s): Required Intervention