MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING

Model Number	H7493952832400
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the right anterior tibial artery.After a non-bsc guidewire crossed the lesion, a 4.00x32mm promus premier drug-eluting stent was advanced but failed to cross the lesion.During the procedure, the device became stuck on the guidewire and the device could not be advanced nor could not be removed from the guidewire.The device was removed together with the guidewire and procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Updated: device evaluated by mfr., method codes, result codes and conclusion codes.Device evaluated by mfr: promus premier us mr 4.00x32mm stent delivery system was returned for analysis broken into two sections.A visual and microscopic examination of the crimped stent found stent damage.Damage was noted to the proximal and mid sections of the stent and to the most distal stent strut row.The balloon cones were reviewed.The balloon wings were folded and were not subjected to positive pressure.The proximal balloon cone had been distorted by the damage stent.No issues noted with the distal balloon cone.A visual and tactile examination of the hypotube identified multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed a shaft break on the distal side of wire exchange port.The outer shaft polymer extrusion had been stretched proximally of inner shaft polymer extrusion break site.Multiple sites of stretching and bunching were noted along length of shaft polymer extrusion.A guidewire was returned stuck within the wire lumen of distal portion of the device.The returned wire outer diameter was measured 0.0135 which was the correct size per dfu the device is designed for guidewire.A visual and microscopic examination found no damage to the tip.No other issues were identified during the product analysis.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.(b)(4).
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the right anterior tibial artery.After a non-bsc guidewire crossed the lesion, a 4.00x32mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.During the procedure, the device became stuck on the guidewire and the device could not be advanced nor could not be removed from the guidewire.The device was removed together with the guidewire and procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6987593
• Report Number: 2134265-2017-10806
• Device Sequence Number: 1676451
• Product Code: NIQ
• UDI-Device Identifier: 08714729844990
• UDI-Public: 08714729844990
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• 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): 10/12/2017

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: 08/08/2018
• Device Model Number: H7493952832400
• Device Catalogue Number: 39528-3240
• Device Lot Number: 0020308709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR