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

Model Number H7493924215050

Device Problems Break (1069); Device Damaged by Another Device (2915); Difficult to Advance (2920)

Patient Problem Intimal Dissection (1333)

Event Date 11/16/2015

Event Type  Injury  

Manufacturer Narrative

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

Same case as mfr # 2134265-2015-08621.It was reported that the stent was damaged and became dislodge.As the physician was treating a chronic total occlusion of the right coronary artery (rca).The physician advanced the 2.50x38mm promus premier stent into the non-bsc guiding catheter.The stent crossed the guidezilla¿ extension catheter and got hung up on the collar.The crimped stent struts became deformed and the stent dislodged from the delivery device.The physician was able to pull back the delivery device and noticed the stent wasn¿t attached.He then pulled the guidezilla¿ back and the shaft broke.The leading portion of the guidezilla¿ was in the proximal segment of the vessel and the rest of it was left in the non-bsc guiding catheter.The physician went in with a balloon to trap the guidezilla¿ that was remaining in the non-bsc guiding catheter and remove everything as a unit.The dislodged stent was found in the distal portion of the guidezilla.He was able to rotablate but unable to stent again due to lost wire access at the dissection site.The physician advanced a new non-bsc guiding catheter in and took pictures, he saw there was a large dissection he tried to put the wire down to rewire the vessel, they could not get into the true lumen therefore, the physician stopped the procedure.The patient is in stable condition.The patient will return after six weeks to complete the procedure.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a guidezilla guide extension catheter in 2 pieces, with blood and contrast on the lumen.The tip of the device was flattened.Microscopic and tactile examination revealed numerous kinks in both the shaft and hypotube.The outer diameter (od) of the undamaged portion of the distal shaft was measured exceeded specifications.Microscopic examination revealed a complete separation at the collar/proximal shaft bond.There was damage to the collar.The ptfe was pulled out of the collar and was attached to the distal shaft.The interventional device used in the procedure was not returned with the complaint device.A promus element plus unit was attempted to be inserted in the collar of the device; however, due to the condition of the collar and the separation of the shaft, functional testing could not be performed.The manufacturing batch record review confirmed 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 mfr # 2134265-2015-08621.It was reported that the stent was damaged and became dislodge.As the physician was treating a chronic total occlusion of the right coronary artery (rca).The physician advanced the 2.50x38mm promus premier stent into the non-bsc guiding catheter.The stent crossed the guidezilla extension catheter and got hung up on the collar.The crimped stent struts became deformed and the stent dislodged from the delivery device.The physician was able to pull back the delivery device and noticed the stent wasn't attached.He then pulled the guidezilla back and the shaft broke.The leading portion of the guidezilla was in the proximal segment of the vessel and the rest of it was left in the non-bsc guiding catheter.The physician went in with a balloon to trap the guidezilla that was remaining in the non-bsc guiding catheter and remove everything as a unit.The dislodged stent was found in the distal portion of the guidezilla.He was able to rotablate but unable to stent again due to lost wire access at the dissection site.The physician advanced a new non-bsc guiding catheter in and took pictures, he saw there was a large dissection he tried to put the wire down to rewire the vessel, they could not get into the true lumen therefore, the physician stopped the procedure.The patient is in stable condition.The patient will return after six weeks to complete the procedure.

• Brand Name: GUIDEZILLA¿
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): 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: 5300694
• MDR Text Key: 33582620
• Report Number: 2134265-2015-08524
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123765
• 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: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: H7493924215050
• Device Catalogue Number: 39242-1505
• Device Lot Number: 17790189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2015
• 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): Required Intervention
• Patient Age: 53 YR