MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ATLANTIS¿ SR PRO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H749389420

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the catheter got stuck in stent.The target lesion was located in the left anterior descending artery.An atlantis¿ sr pro imaging catheter was used for diagnosis.During the procedure, pre dilatation was performed with a 4.0x8 bsc balloon catheter and a non bsc stent was implanted thereafter.Subsequently, the physician inserted the catheter to diagnose; however, the implanted stent shortened from the extrusion by the catheter.The physician then attempted to remove the catheter; however, resistance was encountered.Excessive force was then applied to remove the catheter and it was then observed that the distal outer sheath was damaged.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was returned for evaluation.Device analysis revealed a damage on the guidewire exit port assembly.No other visual damages were encountered upon visual inspection.A test guidewire (0.014") was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.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

It was reported that the catheter got stuck in stent.The target lesion was located in the left anterior descending artery.An atlantis¿ sr pro imaging catheter was used for diagnosis.During the procedure, pre dilatation was performed with a 4.0x8 bsc balloon catheter and a non bsc stent was implanted thereafter.Subsequently, the physician inserted the catheter to diagnose; however, the implanted stent shortened from the extrusion by the catheter.The physician then attempted to remove the catheter; however, resistance was encountered.Excessive force was then applied to remove the catheter and it was then observed that the distal outer sheath was damaged.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

• Brand Name: ATLANTIS¿ SR PRO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5554324
• MDR Text Key: 42069667
• Report Number: 2134265-2016-02675
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K063312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

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: 07/30/2016
• Device Model Number: H749389420
• Device Catalogue Number: 38942
• Device Lot Number: 18252393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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: 66 YR