MAUDE Adverse Event Report: INVATEC SPA SUBMARINE RAPIDO; CATHETER, PERCUTANEOUS

Catalog Number SBR030040135

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the submarine rapido pta balloon catheter was received within a zippered closure plastic pouch and loosely coiled within its opened labeled pouch.The lot number data printed on the hub is consistent with the lot number data printed on the pouch label and reported event.No ancillary devices nor procedural images were received for analysis.The submarine rapido catheter was received with the balloon chamber in a post-inflation profile, (e.G.Not tightly wrapped and winged) (photo 6).Crystalline residue was noted on the exterior of the catheter.A 10cc water filled syringe was attached to the hub luer lock and negative pressure was applied but could not be maintained.The inability to maintain negative pressure is an indicator of communication between the inflation lumen and the environment.The water filled syringe was pressurized, and longitudinal tear was noted in the proximal end of the balloon chamber.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to a submarine rapido pta balloon along with non-medtronic 6fr sheath, 0.014 guide wire and 5mm spider fx embolic protection during procedure to treat a calcified lesion in the right mid common carotid artery with 80% stenosis.The vessel diameter and lesion length are 4mm and 30mm respectively.The device was prepped per ifu.The device was not passed through a previously deployed stent.No resistance was encountered when advancing the device.Negative prep was not performed.A non-medtronic inflation device was used to inflate the balloon.It was reported that during use of the product, the balloon failed to be inflated at 16 atm.No leaks were noted.The device was safely removed from the patient and another product was used to complete the procedure.The inflation of the replacement device was carried out using a different non-medtronic inflation device.There was no patient injury reported.

• Brand Name: SUBMARINE RAPIDO
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10682269
• MDR Text Key: 211695479
• Report Number: 3004066202-2020-00030
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2022
• Device Catalogue Number: SBR030040135
• Device Lot Number: 1M005119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2019
• 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
• Patient Weight: 70