MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK? PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number H749236310030

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014 same case as mdr id: 2134265-2014-05299.It was reported that a leak occurred.The stenosed target lesion was located in the moderately tortuous and severely calcified vessel.A 1.50mm rotalink¿ plus and 330cm rotawire¿ and wireclip¿ torquer were used to treat the target lesion.During procedure, a leaking sound was heard from the advancer.The procedure was completed with another of the same device.There were no patient complications reported and the patient¿s condition is good.However, device analysis revealed a tear in the sheath around the coil and that saline was being expelled through the sheath.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: device was returned for analysis.A visual examination of the complaint unit was carried out.The advancer knob was returned in a backward position, it was loosened and advanced in order to inspect the handshake connection.The handshake connection was inspected and no damage was noted.A handshake connection test was attempted to examine the integrity of the connection and no issues were noted.The coil was observed to be kinked upon inspection.The complaint unit was wet tested and upon inspection it was noted there was a tear in the sheath around the coil and that saline was not reaching the end of the sheath but was being expelled through the sheath.As a result the device could not be successfully wet tested.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

• Brand Name: ROTALINK? PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4078085
• MDR Text Key: 4826632
• Report Number: 2134265-2014-05434
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0016783230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2014
• 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