MAUDE Adverse Event Report: COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number AB14W040100150

Device Problem Burst Container or Vessel (1074)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was using a nano cross pta balloon catheter to treat the proximal, mid and distal right common iliac artery with a non-medtronic 6fr sheath and guide wire. The device was prepped per ifu with no issues identified. The balloon was inflated using a non-medtronic inflation device. The vessel was moderately tortuous and the chronic totally occluded lesion was severely calcified. It was reported that a longitudinal burst occurred at 6atm during inflation. There was difficulty removing the catheter and the balloon catheter was stretched out. It was reported that majority of the balloon remains in the patient and surgery is planned at a later date to remove remaining fragments.

Manufacturer Narrative

Device evaluation the nanocross elite was inspected and found the distal end was fractured off. The balloon showed a radial bust at the proximal location of the balloon. The blue gw lumen measured approximately 56cm out from the radial burst location. A kink to the catheter shaft was noted at approximately 160cm from the distal end. The working length was approximately 195cm. The marker bands were no observed. It is likely the segment of the catheter where the marker bands were attached fractured off. The distal segment of the catheter which had fractured off was not returned. The distal tip of the gw catheter lumen was inspected under microscope. The distal tip showed a ductile type fracture face with noted stretching. The radial balloon burst area was inspected under microscope. The observed kink was inspected under microscope and observed a blue gw lumen was compressed. A 0. 035" guidewire was loaded through the returned 6f sheath in efforts to see if the distal segment of the catheter was lodged within the sheath. There was no sign of debris stuck inside the introducer lumen. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: no snare attempt was made. The 6x10 sheath was removed as the physician believed the balloon fragment remained in the sheath. The fragment was not in the sheath, so an attempt was made to bareback a trailblazer over the 014 wire unsuccessfully. Pre-dilation was then performed to attempt to advance a 7x25 sheath into the iliac. Due to heavy calcification from the iliac down to the common femoral, it was difficult to get the sheath in. The balloon fragment was located in the right common iliac patient had surgery to remove the balloon fragment. Endarterectomy of the cfa and bypass of the iliac also performed. Patient is stable and recovering from surgery. If information is provided in the future, a supplemental report will be issued.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8878250
• MDR Text Key: 153796773
• Report Number: 2183870-2019-00397
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/22/2022
• Device Catalogue Number: AB14W040100150
• Device Lot Number: A836690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/09/2019 Patient Sequence Number: 1