MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS? SR PRO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H749389420

Device Problems No Display/Image (1183); Retraction Problem (1536); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

Same case: 2134265-2015-03267, 2134265-2015-03266, and 2134265-2015-03277.It was reported that automatic pullback failure occurred.During a percutaneous coronary intervention (pci), an ilab ultrasound imaging system was used in conjunction with an atlantis¿ sr pro imaging catheter and a sled to visualize the left anterior descending artery.However, it was noted that the catheter failed to show an image.The imaging catheter was then changed with another atlantis¿ sr pro imaging catheter;however, the problem still occurred.It was then noted that a motor drive unit (mdu) overload has occurred and the automatic pullback failed.The procedure was not completed due to this event.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was returned for evaluation.Device analysis revealed that the telescope assembly was able to properly pull back, advance, or retract.No issues were found, the device appears to be in good conditions.It was observed that the catheter flushed normally.The hub flaps appeared normal and a good click sound was heard during insertion into the mdu system.Impedance testing shows a good unit wave form.By using a test pullback sled assembly, the catheter was able to properly pull back manually and automatically.The sled was not returned with the catheter the test was performed with a control sled in the complaint lab.The catheter was properly recognized by the imaging system when plugged into the mdu and no connection issues or errors were detected during its testing.During image characterization testing, a good square image appeared in the ilab system.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Same case: 2134265-2015-03267, 2134265-2015-03266, and 2134265-2015-03277.It was reported that automatic pullback failure occurred.During a percutaneous coronary intervention (pci), an ilab ultrasound imaging system was used in conjunction with an atlantis¿ sr pro imaging catheter and a sled to visualize the left anterior descending artery.However, it was noted that the catheter failed to show an image.The imaging catheter was then changed with another atlantis¿ sr pro imaging catheter;however, the problem still occurred.It was then noted that a motor drive unit (mdu) overload has occurred and the automatic pullback failed.The procedure was not completed due to this event.No patient complications were reported and the patient's status was stable event.No patient complications were reported and the patient's status was stable.

• Brand Name: ATLANTIS? SR PRO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4803025
• MDR Text Key: 5929069
• Report Number: 2134265-2015-03268
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K063312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2015

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: 08/28/2015
• Device Model Number: H749389420
• Device Catalogue Number: 38942
• Device Lot Number: 17238210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• 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