MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STINGRAY CATHETER; CATHETER, PERCUTANEOUS

Model Number H749M1000B0

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as: 2134265-2015-08983.It was reported that balloon catheter burst occurred.The chronic totally occluded (cto) target lesion was located in the left anterior descending (lad) artery.A stingray catheter was used in conjunction with a stingray guidewire and a crossboss catheter to treat the target lesion.The physician utilized the three devices for an antegrade dissection re-entry method in crossing the cto lesion.When the physician successfully crossed the lesion with an unspecified cto specialty gudiewire and then established the guidewire in the sub-intimal plane as visible through fluoroscopy injections, the physician passed the crossboss catheter down over the guidewire while remaining in the sub-intimal plane.After which, the physician took the first stingray catheter along with the stingray guidewire and brought the devices into the sub-intimal plane.The physician then inflated the stingray catheter at 4 atmospheres (atm) however, it was noticed that the balloon burst.The stingray catheter was then pulled and the second stingray catheter was used and successfully delivered to the desired location.Upon inflation of the second stingray catheter at 4 atm, the device stayed inflated for a short duration just enough to deliver and cross the stingray guidewire.However, it was unable to retain the contrast since the device burst as well.Subsequently, since the stingray guidewire was able to re-enter the true lumen, the physician proceed in delivering the unspecified stents across the lesion and re-vascularized the artery.No patient complications were reported and the patient's status is stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Microscopic examination of the balloon revealed no damage.Functional testing was performed by attaching an inflation device filled with water to the device.When positive pressure was applied, a stream of water emitted from the guidewire lumen.There was a hole in the inner lumen 20mm from the proximal weld.The hole is consistent with a guidewire puncture.Microscopic examination presented no irregularities in the shaft material that could have contributed to the damage.The shaft was kinked 2.45cm from the hub.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

Same case as: 2134265-2015-08983.It was reported that balloon catheter burst occurred.The chronic totally occluded (cto) target lesion was located in the left anterior descending (lad) artery.A stingray catheter was used in conjunction with a stingray guidewire and a crossboss catheter to treat the target lesion.The physician utilized the three devices for an antegrade dissection re-entry method in crossing the cto lesion.When the physician successfully crossed the lesion with an unspecified cto specialty guidewire and then established the guidewire in the sub-intimal plane as visible through fluoroscopy injections, the physician passed the crossboss catheter down over the guidewire while remaining in the sub-intimal plane.After which, the physician took the first stingray catheter along with the stingray guidewire and brought the devices into the sub-intimal plane.The physician then inflated the stingray catheter at 4 atmospheres (atm) however, it was noticed that the balloon burst.The stingray catheter was then pulled and the second stingray catheter was used and successfully delivered to the desired location.Upon inflation of the second stingray catheter at 4 atm, the device stayed inflated for a short duration just enough to deliver and cross the stingray guidewire.However, it was unable to retain the contrast since the device burst as well.Subsequently, since the stingray guidewire was able to re-enter the true lumen, the physician proceed in delivering the unspecified stents across the lesion and re-vascularized the artery.No patient complications were reported and the patient's status is stable.

• Brand Name: STINGRAY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5318007
• MDR Text Key: 34127068
• Report Number: 2134265-2015-08982
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K080987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

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: 05/22/2016
• Device Model Number: H749M1000B0
• Device Catalogue Number: M-1000
• Device Lot Number: 17145411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2014
• 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
• Patient Age: 63 YR