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

Model Number H749236310020

Device Problem Entrapment of Device (1212)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Perforation of Vessels (2135)

Event Type  Death  

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 the rota burr was stuck in the lesion and caused vessel perforation and patient death.The target lesion was located in the left anterior descending (lad) artery.Initially, the physician advanced an unspecified balloon but it failed to cross the lesion.A 1.25mm rotalink¿ plus was then selected for use to perform rotational atherectomy.During the first ablation, it was noticed that the burr stalled in the lesion and the physician was unable to remove it.Numerous troubleshooting methods were attempted however, none of them successful.Finally, the physician decided to pull the burr very hard and the device dislodged however, perforated the patient's artery.A balloon pump was then inserted and cpr was administered for several minutes.The patient's condition continued to deteriorate and unfortunately passed away.

Manufacturer Narrative

The device was returned for analysis.The advancer, the burr, sheath, coil, and handshake connections were microscopically and visually examined.The advancer and burr units were received detached.The advancer knob was received loosened in a midway position.There was blood in the sheath and inside the coil catheter.Due to the dried blood, the rotawire was unable to be removed from the device.Functional testing was performed by connecting the rotablator rotalink plus device to the rotablator control console system.The device was not able to get any speed and the stall light came on the console.The advancer was dismantled and the turbine was found to be corroded and the ultem was found to be melted.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.Device analysis determined the condition of the returned device was consistent with the reported information.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 the rotaburr was stuck in the lesion and caused vessel perforation and patient death.The target lesion was located in the left anterior descending (lad) artery.Initially, the physician advanced an unspecified balloon but it failed to cross the lesion.A 1.25mm rotalink¿ plus was then selected for use to perform rotational atherectomy.During the first ablation, it was noticed that the burr stalled in the lesion and the physician was unable to remove it.Numerous troubleshooting methods were attempted however, none of them successful.Finally, the physician decided to pull the burr very hard and the device dislodged however, perforated the patient's artery.A balloon pump was then inserted and cpr was administered for several minutes.The patient's condition continued to deteriorate and unfortunately passed away.

• 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: 6408201
• MDR Text Key: 70054904
• Report Number: 2134265-2017-02042
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)20181130(10)0020059452
• 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: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: H749236310020
• Device Catalogue Number: 23631-002
• Device Lot Number: 0020059452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2016
• 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 Outcome(s): Death; Required Intervention
• Patient Age: 87 YR