MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3851

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Date 05/15/2020

Event Type  Injury  

Event Description

It was reported that removal difficulties were encountered and device interaction occurred.In 2017, percutaneous coronary intervention was performed at another hospital with a 3.5/12 synergy stent placed from the left main trunk (lmt) to the proximal left anterior descending (lad) artery.In may 2020, severe stenosis was observed distal of the stent that was originally placed.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified mid lad.A 10mmx3.00mm wolverine coronary cutting balloon was used for treatment and dilated at 8 atmospheres.During removal, severe resistance was met and upon pulling the device together with the wire, the previously placed stent came out together with the wolverine balloon.There were no changes to the patient's condition.Intravascular ultrasound was performed and another wolverine was used.A non-bsc stent was deployed on lad#7(mid lad) treatment section, and in lad#6(proximal lad/lmt) where the previously placed synergy stent had been accidentally removed.No further complications nor injuries were reported.The physician additionally noted that it seemed that mal-apposition occurred of the previous stent in the proximal area of the stent that was placed upon pre-ivus and the balloon may have caught in that area.

Manufacturer Narrative

Device evaluation by mfr: wolverine device3.00x10, catheter batch#24824881 038 was returned for analysis.The device was returned with the balloon inside a severly stretched and damaged stent.For investigation purposes the stent was remove from the device.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was returned with the balloon inside a damaged stent.One of the blades of the device was found to have gone through the stent.After removing the damaged stent the returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure for 30 seconds using digital timer without issue.A vacuum was then applied.The inflation device was verified at the rated burst pressure, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.A visual and microscopic examination found all of the blades to be present, undamaged and fully bonded to the balloon material.The device was received with the balloon inside a severely damaged stent.The proximal end of one of the blades and its blade pad had been forced through the first row of proximal struts of the damaged stent.This would suggest that the balloon of the device was not fully deflated on removal from the patient.A microscopic examination identified damaged to the tip.This type of damage is consistent with the device encountering resistasnce when attempting to cross the lesion.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found the hypotube to be kinked at more than one location.This type of damage is consistent with the device encountering resistance and the user applying excessive force when attempting to cross the lesion.No other issues were noted with the returned device which may have potentially contributed to the complaint incident.

Event Description

It was reported that removal difficulties were encountered and device interaction occurred.In 2017, percutaneous coronary intervention was performed at another hospital with a 3.5/12 synergy stent placed from the left main trunk (lmt) to the proximal left anterior descending (lad) artery.In (b)(6) 2020, severe stenosis was observed distal of the stent that was originally placed.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified mid lad.A 10mmx3.00mm wolverine coronary cutting balloon was used for treatment and dilated at 8 atmospheres.During removal, severe resistance was met and upon pulling the device together with the wire, the previously placed stent came out together with the wolverine balloon.There were no changes to the patient's condition.Intravascular ultrasound was performed and another wolverine was used.A non-bsc stent was deployed on lad#7(mid lad) treatment section, and in lad#6(proximal lad/lmt) where the previously placed synergy stent had been accidentally removed.No further complications nor injuries were reported.The physician additionally noted that it seemed that mal-apposition occurred of the previous stent in the proximal area of the stent that was placed upon pre-ivus and the balloon may have caught in that area.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10146628
• MDR Text Key: 194951526
• Report Number: 2134265-2020-06863
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0025205129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYNERGY DRUG-ELUTING STENT; SYNERGY DRUG-ELUTING STENT; SYNERGY DRUG-ELUTING STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 63