MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Catalog Number H802228240020

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problem Perforation (2001)

Event Date 10/28/2015

Event Type  malfunction  

Event Description

Rotational atherectomy and ptca of the rca performed.With the cook needle, the right femoral artery was accessed and a 7.5 french sheath was inserted.The right femoral vein was accessed and a 6 french sheath was inserted.Her temporary pacemaker wire was then advanced in the right ventricle.Threshold was checked and pacer was left on standby.Using the jl4 catheter, selective left coronary angiogram was performed.The stent in the left main artery appeared patent and decision was made to proceed with angioplasty of the right coronary artery.Ar-1 guiding catheter of 7 french in size with side holes was used.This catheter was not given good support and a jr with side holes catheter was used.However, this catheter did not engage well.A 7 french ar-1 guiding catheter with side holes was reused.A pilot wire was then advanced in the right coronary artery, a 2.5 x 15 mm balloon was used in the mid right coronary artery as an anchor.An attempt was made to advance the guiding catheter.However, guiding catheter did not engage well.This balloon and wire were then removed and with the rotablator wire, the lesion in the right coronary artery was crossed.Then using the 1.25 mm burr, attempt was made to do a rotational atherectomy of the right coronary artery.It was difficult to advance the burr even at the ostium and a rotational atherectomy was performed in the entire proximal to mid portion.It was very difficult to cross the tandem lesions in the mid right coronary artery.The cutting time was more than 10 minutes.Subsequently, the burr went through the mid right coronary artery.However, it did appear to go in the wrong direction and a perforation in the right coronary artery with the cutting of the wire was suspected.Then a pilot wire was used and a lesion in the mid right coronary artery was crossed.Subsequently, a 2.5 x 30 mm long balloon was used and prolonged inflations were performed in the mid right coronary artery.There was thinning around the right coronary artery.However, overall, perforation appeared to be contained.The guidewire was advanced in the mid right coronary artery before they sewed the balloon in place.Small loculated effusion on echo without tamponade.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 47215 lakeview blvd.; fremont CA 94538
• MDR Report Key: 5213170
• MDR Text Key: 30848903
• Report Number: 5213170
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/11/2017
• Device Catalogue Number: H802228240020
• Device Lot Number: 17696513
• Other Device ID Number: GTIN= 08714729185871
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR