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

Model Number H749236310020

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

It was reported that the shaft had a crack.The target lesion was located in the left anterior descending artery.A 1.25 mm and 1.50 mm rotalink plus were used in the atherectomy procedure.Platforming was done successfully prior to insertion of the devices into the patient.During the procedure, it was noted that the 1.25 mm burr stalled in the left main artery.The device was replaced with the 1.50 mm burr, however the device also stalled.The device was removed and it was further noted there was a crack in the black portion of the burr shaft.The procedure was completed with this device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Manufacturer Narrative

Corrected: upn from h749236310030 to h749236310020, catalog/model # from 23631-003 to 23631-002.Device evaluated by mfr.: the device was returned for evaluation.A visual examination of the device noted that the strain relief of the catheter was free from damage.The handshake connection was inspected and no damage was noted.No issues were noted during a tug test.A tear in the sheath around the distal coil was found during wet test and saline was not reaching the end of the sheath but was being expelled through the sheath.The device was dismantled and the ultem was found to be melted.There was also corrosion noted around the turbine of the device.Corrosion was also noted around the burr.It is likely the corrosion occurred due to the presence of saline around these areas while in transit back for investigation.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 most likely occurred prior to direct patient contact.(b)(4).

Event Description

It was reported that the shaft had a crack.The target lesion was located in the left anterior descending artery.A 1.25 mm and 1.50 mm rotalink¿ plus were used in the atherectomy procedure.Platforming was done successfully prior to insertion of the devices into the patient.During the procedure, it was noted that the 1.25 mm burr stalled in the left main artery.The device was replaced with the 1.50 mm burr, however the device also stalled.The device was removed and it was further noted there was a crack in the black portion of the burr shaft.The procedure was completed with this device.There were no patient complications 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3825131
• MDR Text Key: 4447570
• Report Number: 2134265-2014-02910
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2014

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: 12/31/2015
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 0016654410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 05/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2014
• 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