MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CHARGER¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939206070470

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that balloon rupture and tip detachment occurred.The 50-65% stenosed target lesion was located in the non tortuous and moderately calcified superficial femoral artery (sfa).After implanting a 8x40mm non-bsc stent, a 7.0 x40, 75cm charger¿ balloon catheter was advanced for post dilatation; however, upon the first inflation at 20 atmospheres, the balloon ruptured and the tip of the catheter broke.Snaring was done and the procedure was completed.No patient complications were reported and the patient's status was fine.

• Brand Name: CHARGER¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6590539
• MDR Text Key: 75959516
• Report Number: 2134265-2017-05088
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Model Number: H74939206070470
• Device Catalogue Number: 3920607047
• Device Lot Number: 0020314061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STENT: 8X40MM EVERFLEX
• Patient Outcome(s): Required Intervention