MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER

Catalog Number	1012278-30
Medical Device Problem Codes	Deflation Problem (1149); Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported the 4.0x30mm rx trek balloon dilatation catheter (bdc) was used in the pulmonary artery.The bdc was inflated and deflated two or three times to 6-8 atmospheres (atm) however after the last inflation, the balloon would not deflate.The physician decided to over inflate the balloon in order to rupture it.After the balloon burst, the bdc was being removed when resistance was met and the hypotube separated.A snare device was used to remove the separated portion of the device, resulting in a clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed medwatch report, return analysis noted an unknown whisper guide wire returned frozen in the guide wire lumen of the rx trek catheter.The polymer coating was noted to be damaged.Per the account, the polymer damage likely occurred during the attempt to remove the separated portion of the rx trek.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual inspection was performed on the returned device.The reported separation was confirmed.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.The reported difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.A review of the lot 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 identified no other similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device, separation, foreign body removal, additional treatment and delay appear to be related to circumstances of the procedure.It was reported that the procedure was to treat a pulmonary artery.It should be noted he coronary dilatation catheters (cdc), trek rx and mini trek rx, global, information for use (ifu) states: the trek rx and mini trek rx coronary dilatation catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction and balloon dilatation of a stent after implantation (balloon models 2.00 mm ¿ 5.00 mm only).In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Device code 1494: incorrect anatomyh6: device code 1494 added.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8870490
• Report Number: 2024168-2019-10645
• Device Sequence Number: 1938437
• Product Code: LOX
• UDI-Device Identifier: 08717648138744
• UDI-Public: 08717648138744
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 1012278-30
• Device Lot Number: 90429G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention