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

Model Number H7493924215050

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of a guidezilla guide extension catheter in two pieces, a filterwire, and a stent.The stent of the promus premier used in the procedure was compressed and loose from the balloon.Microscopic examination and tactile inspection revealed numerous kinks throughout the shaft.The inner diameter (id) of the guidezilla was measured at the distal tip using a calibrated pin gauge set.The id at was 0.057¿ meeting specifications.A.057¿ tooling qualified mandrelwas inserted through the tip with no resistance.Microscopic examination revealed a partial separation at the collar/shaft area.Microscopic examination presented no damage or irregularities in the tip.The stent delivery system (sds) used in the procedure was not returned for analysis.Due to the condition of the returned devices, functional testing could not be performed.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 mdr#20134265-2015-05388 & 2134265-2015-07389.Reportable based on the product analysis completed on 24 sept 2015.It was reported difficulty advancing a stent catheter through the guide extension catheter and the stent was dislodged.The target lesion was located in a proximal saphenous vein graft (svg) to the left anterior descending artery (lad).The physician selected the a filterwire.To insert through a 6f guidezilla extension catheter.The lesion was pre dilated with a 2.15x15 emerge balloon.The physician advanced a 4.0x24mm promus premier stent.During the advancement of the stent through the guidezilla, there was resistance in the guidezilla.After pushing, the physician stated it was free, the resistance was gone.When the stent was advanced into the actual saphenous vein graft, it noted on the fluoroscopy that there was no stent on the actual delivery system.The wire, stent, balloon and the guidezilla were all removed from the patient at the same time.The stent was jammed/crushed and is between the actual wire and the entry point of the guidezilla.The procedure was completed with a different wire inserted in the svg to the lad, and a new promus premier 4.0 x 24 stent was deployed in the proximal potion of the svg.No patient complications were reported and the patient status was fine.However, the returned product analysis revealed that the shaft fractured.

• Brand Name: GUIDEZILLA¿
• 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: 5169306
• MDR Text Key: 29009085
• Report Number: 2134265-2015-07048
• 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
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: H7493924215050
• Device Catalogue Number: 39242-1505
• Device Lot Number: 18031644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2015
• 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 Age: 64 YR