MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	AB35W12040080
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used an evercoss pta balloon with a 7fr sheath and an unknown guidewire for the treatment of an unknown lesion type in the iliac vein (diameter 12mm).Embolic protection was not used.The ifu was followed and device was prepped without issue.The balloon was inflated using an unknown inflation device with a contrast/saline fluid to a pressure of 8 atm.It was reported that a break occurred at the sheath during removal.The detached portion remains in the patient.It is unknown if resistance was encountered or if excessive force was used.In order to complete the procedure, the remaining balloon fragment was stented over within the vessel (unknown size stent used).No patient injury reported.
Additional Manufacturer Narrative
Device evaluation summary: sanguine residue was noted within the inflation lumen port of the y-manifold of the returned evercross dilatation catheter.The proximal end of the balloon chamber exhibited radial and longitudinal tearing.The inner guidewire lumen exhibited a separation face at the distal end of the balloon chamber¿s proximal marker band.The inner guidewire lumen exhibited longitudinal stretching just proximal of the proximal edge of the proximal radiopaque marker band, (the distance between the parallel light reflections narrows down).The distal edge of the radiopaque marker exhibits an oval shape.Only approximately 76.3cm of the catheter distal of the y-manifold¿s printed strain relief was returned for evaluation.Over 40mm of balloon chamber length and inner guidewire lumen were not returned.The distal marker band and distal tip were not returned.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6840177
• Report Number: 2183870-2017-00369
• Device Sequence Number: 1430743
• Product Code: LIT
• UDI-Device Identifier: 00821684062319
• UDI-Public: 00821684062319
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• 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,Followup
• Report Date (Section B): 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2020
• Device Catalogue Number: AB35W12040080
• Device Lot Number: A419491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR