MAUDE Adverse Event Report: SURMODICS TELEMARK MICROCATHETER

Model Number SURMC135

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/12/2020

Event Type  malfunction  

Event Description

Physician applied appropriate/ moderate pressure with torqueing the telemark to advance the catheter across the calcified lesion, but it would not advance.He then removed the telemark catheter and observed angiographically that the radiopaque marker was detached and located in the mid circumflex.He attempted to remove the marker band but was unsuccessful.He was able to deliver a turnpike lp microcatheter just pass the lesion and exchange for a rotoblator wire.The physician then used the rotoblator for the vessel proximal to the lesion and detached marker band successfully.He then placed a guide wire subintimal and used a bsc stingray re-entry device to guide the coronary wire back into the true lumen pass the detached marker band and introduced a xience sierra coronary stent across the lesion and detached marker band and deployed successfully.

Manufacturer Narrative

The device was not returned for evaluation.A review of the batch history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported event appears to be related to the circumstances of the procedure.It was reported that the procedure was performed in a severely calcified lesion.The ifu states the contraindication: do not use the microcatheter in advanced calcified lesions and a warning to not manipulate the device if any resistance is felt.The investigation determined the reported complaint was related to device misuse.The field reps and staff were retrained on the device use.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: TELEMARK MICROCATHETER
• Type of Device: MICROCATHETER
• Manufacturer (Section D): SURMODICS; 9924 w 74th st; eden prairie, mn
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; ballinasloe, galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: jonathan canavan ; ida business park; ballinasloe, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 10448174
• MDR Text Key: 205018798
• Report Number: 3005994106-2020-00088
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K173560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SURMC135
• Device Lot Number: 21903427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 64 YR
• Patient Sex: Male