MAUDE Adverse Event Report: COVIDIEN ENTEER RE-ENTRY BALLOON CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	ENB-375-20-135
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician employed the use of an enteer re-entry balloon catheter and an enteer re-entry guidewire during treatment of a 250mm severely calcified cto (chronic total occlusion-100%) lesion in the patients distal superficial femoral artery (sfa).The patients aortoiliac bifurcation is reported to have been severely tortuous.The ifu was followed and the devices were prepped without issue.The devices did not pass through a previously deployed stent.The enteer was advanced in a contralateral fashion via a 6fr 45cm sheath.The iliacs were reported to be very tortuous.The enteer balloon reached the target site and was inflated.It is reported that during advancement of the enteer wire it appeared to get caught mid catheter and the wire ended up puncturing the balloon lumen which resulted in loss of balloon pressure.It was reported that the enteer re-entry guidewire was unable to rotate torque but was easily withdrawn.The physician then used a second enteer re-entry balloon catheter and an enteer re-entry guidewire to attempt treatment, but the same issue occurred.The physician was unable to re-enter to complete the procedure.No patient injury was reported.

• Brand Name: ENTEER RE-ENTRY BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7586264
• Report Number: 2183870-2018-00326
• Device Sequence Number: 2074044
• Product Code: DQY
• UDI-Device Identifier: 00821684073797
• UDI-Public: 00821684073797
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K120129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2020
• Device Catalogue Number: ENB-375-20-135
• Device Lot Number: A610513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR