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

Model Number H749236310030

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2016

Event Type  malfunction  

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 a hole in the catheter was noted.The 90% stenosed target lesion was located in the mildly tortuous and calcified left anterior descending (lad) artery.A 1.50mm rotalink¿ plus was selected for use.During the procedure, a hole was noted on the shaft and saline was leaking.The procedure was completed with another of the same device.No patient complication were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was returned for evaluation.Returned product consisted of the rotablator rotalink plus device.The advancer unit and burr unit were received together as a single unit.The advancer knob was received tightened in a backward position.The sheath was microscopically and visually inspected.There was a split/tear in the sheath 22cm from the strain relief on the catheter body housing.There were also, numerous kinks throughout the sheath.Functional testing was performed by connecting the rotablator rotalink plus device to the rotablator control console system.When the drip line was turned on, water started leaking from the hole in the sheath.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that a hole in the catheter was noted.The 90% stenosed target lesion was located in the mildly tortuous and calcified left anterior descending (lad) artery.A 1.50mm rotalink¿ plus was selected for use.During the procedure, a hole was noted on the shaft and saline was leaking.The procedure was completed with another of the same device.No patient complication were reported.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5722340
• MDR Text Key: 47286289
• Report Number: 2134265-2016-04954
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• 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,Followup
• Report Date: 05/17/2016

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: 02/28/2018
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 19055314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• 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
• Patient Age: 79 YR